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The goal of this study is to learn about fertility preservation in the gender-diverse community. The main objectives it aims to understand are to:
Fertility preservation is an important aspect of care for all patients who may have their fertility compromised secondary to disease, medical treatments, age or other circumstances, including treatments for gender dysphoria. An increasing number of transgender male patients (transitioning female to male) are presenting to fertility clinics for fertility preservation. Studies indicate that parenthood is important for this patient population . Therefore, both the Endocrine Society and the World Professional Association for Transgender Health (WPATH) recommend that fertility preservation be discussed with all patients prior to initiation of medical treatments for gender dysphoria.
For transgender male patients, medical treatment is primarily comprised of testosterone, which is often preceded by GnRH agonists (such as leuprolide acetate) to reduce endogenous estrogen production. There are theoretical concerns about the effects of long-standing hormonal treatment on the gonads and future fertility potential. Regardless of the timing of initiation of GnRH agonist and/or testosterone therapy, fertility preservation counseling is an essential aspect of their care. Egg preservation does require the individual to undergo their natal puberty, and for many trans-males, this is undesirable and even contra-indicated from mental health standpoint, as the suicide rate for transgender youth is 10-times the national average. Ovarian tissue cryopreservation is an alternative option for transgender male patients who desire pubertal blockade and testosterone but have not yet gone through female puberty and are therefore not producing mature eggs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryopreservation | Participants will have their gonadal tissue cryopreserved. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oophorectomy | Procedure | Ovary will be removed for fertility preservation. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To optimize techniques for cryopreservation of ovarian tissues, including determining efficacy of cryopreservation techniques. | Without undergoing puberty in one's natal sex, there are no standard of care fertility preservation options available for these patients. The study will aim to optimize techniques for cryopreservation of ovarian tissues by utilizing the best scientific standards for cryopreservation. | [10 years] |
| To investigate factors affecting ovarian tissue and follicles, such as previous treatment with leuprolide acetate, or hormone therapy. | For transgender male patients, medical treatment is primarily comprised of testosterone, which is often preceded by GnRH agonists (such as leuprolide acetate) to reduce endogenous estrogen production. There are theoretical concerns about the effects of long-standing hormonal treatment on the gonads and future fertility potential. The study aims to determine whether factors such as gender-affirming treatment affects the ovarian tissue and follicles by examining tissue donated to research. | [10 years] |
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Inclusion Criteria:Two Categories of participants will be eligible for this study.
Category 1 participants must have all criteria listed below:
Category 2 participants only fall into this category if they are undergoing gender-affirming surgery. They must have all criteria listed below:
Exclusion Criteria:
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Eligible patients who will undergo gender-affirming treatments and for whom standard of care fertility preservation procedures are not available.
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| Name | Affiliation | Role |
|---|---|---|
| Kyle Orwig, PhD | University of Pittsburgh/ University of Pittsburgh Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Magee-Womens Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
The Investigators will publish individual participant data. The investigators will also report each individual participants data back to them. Participants will be identified with unique ID numbers. No identifiable information will be shared.
We will share IPD with the patient (and only the patient) within one year of enrollment. We share study protocol ICF with collaborating sites upon request. De-identified IDP is shared with collaborating sites annually.
De-identified research data will be shared with collaborators via e-mail, and with the broader scientific community via publication and presentations at national/international meetings.
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| ID | Term |
|---|---|
| D000068116 | Gender Dysphoria |
| D007246 | Infertility |
| ID | Term |
|---|---|
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D010052 | Ovariectomy |
| ID | Term |
|---|---|
| D002369 | Castration |
| D013507 | Endocrine Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013519 | Urogenital Surgical Procedures |
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Ovarian Tissue
| Infectious Disease Testing |
| Diagnostic Test |
Infectious Disease Testing will be done on participants. |
|
| D013509 | Gynecologic Surgical Procedures |